There are more than 2,800 CRO’s according to IBISWorld and choosing the right partner can be a difficult choice for clinical trial sponsors looking for the right data management resources. Current and upcoming pipeline projects are critical, and it’s hard to just...
MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
Corrective Action and Preventive Action (CAPA) Adoption for Massive Internal Improvements
Corrective Action and Preventive Action (CAPA) is a process which investigates and solves identified issues by evaluating the causes and taking corrective action to resolve immediate issues. To be ISO 9001 and ISO14001 certified, companies must have a Corrective...
Proven Ways to Meet Key Study Start-up Timelines within Clinical Data Management
By 2043, the cost to brings a new drug to market is estimated to be USD16 billion per compound, according to Moore’s Law. This is partly due to clinical trials becoming more complex and requiring longer follow up timeframes during studies. To mitigate the cost impact,...
EMA Revised Transparency Rules Eliminate the Deferral Mechanism for Clinical Trial Data Publication
With the initial release of the Clinical Trial Information System (CTIS) in January 2022, a digital space was created for the implementation of the EU Clinical Trials Regulation (EU CTR) 536/2014, the law governing the conduct of clinical trials in the EU. A period of...
Understanding the Revised Draft Guidance for Formal Meetings with the FDA
Are you looking for rapid feedback from the FDA on a specific topic related to your product development program? Wondering which meeting request you should submit? Let’s delve into the latest updates. On September 22, 2023, the FDA released the eagerly anticipated...
Plain Language Summary of Publications: A Key Step To Build Transparency With The Patient Community
Plain Language Summary for Publications (PLS‑P) is a document born from the growing need to make scientific research and information more understandable to a broader audience. Technical language and terminologies used in scholarly articles can act as a barrier to...
What You Need to Know About Phase 1 Clinical Trial Designs and Bioequivalence (BE)/Bioavailability (BA) in the US and EU
Phase 1 clinical trials occurred in 2,784 instances, accounting for nearly 41 percent of all clinical trials globally, according to recent 2022 data (source). In general, there are more Phase 1 clinical trials than Phase 2 or Phase 3 due to the exploratory nature of...
Clinical Data Managers Should Do These Three Things for Any Post-Production Changes
Post production changes in clinical data management can be difficult to navigate, and a lack of talented pharmaceutical industry resources has driven up demand for Clinical Data Managers . In the last 4 years alone, massive growth has come for clinical data managers...
FDA and the Real-World: Key Changes from Draft to Final Guidance on RWD and RWE
As the FDA explores the complexities of using real-world data to provide evidence for regulatory decision-making, sponsors face the challenge of staying updated with the evolving definitions and standards. Recently, the FDA released its finalized "Guidance for...